A study is to evaluate recurrence-free survival in participants with high-risk non-muscle-invasive bladder cancer who harbor fibroblast growth factor receptor mutationor infusion and who recurred after bacillus calmette-guerin therapy treated with erdafitinib.

A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions - THOR 2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/036009

Enrollment

280

Registered

2021-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N33- Bladder disorders in diseases classified elsewhere

Interventions

Intervention1: Erdafitinib: Participants will receive 8mg erdafitinib daily dose orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxic

Eligibility

Inclusion criteria

Inclusion criteria: - Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed - Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions - Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants - Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only) - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1 - Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study - A woman of childbearing potential must have a negative pregnancy test (beta-hCG [beta-human chorionic gonadotropin]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3) - Adequate bone marrow, liver, and renal function as specified in the protocol

Exclusion criteria

Exclusion criteria: - Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder - Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder - Prior treatment with an FGFR inhibitor - Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy - Current central serous retinopathy or retinal pigment epithelial detachment of any grade

Design outcomes

Primary

Measure	Time frame
Recurrence-Free Survival (RFS)Timepoint: Recurrence-Free Survival (RFS)	—

Secondary

Measure	Time frame
Change from Baseline in EORTC QLQ- Non- Muscle-Invasive Bladder Cancer (NMIBC) 24Timepoint: Baseline up to 4 years;Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30Timepoint: Baseline up to 4 years;Change from Baseline in EuroQol European Quality of Life – 5 Dimensions-5 Levels (EQ-5D-5L)Timepoint: Baseline up to 4 years;Change from Baseline in Patient’s Global Impression of Change (of cancer) (PGIC)Timepoint: Baseline, Cycle 2 Day 1 and end of treatment (up to 2 years) (each cycle is of 28 days);Change from Baseline in Patient’s Global Impression of Severity (of cancer) (PGIS)Timepoint: Baseline up to 4 years;Disease-Specific SurvivalTimepoint: Up to 4 years;Number of Participants with Adverse eventsTimepoint: Up to 4 years;Overall SurvivalTimepoint: Up to 4 years;Plasma Concentration of ErdafitinibTimepoint: Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28 days);Recurrence-Free SurvivalTimepoint: Months 6, 12, and 24;Recurrence-Free Survival 2 (RFS2)Timepoint: Up to 4 years;RFS by Central Histopathologic ReviewTimepoint: Up to 4 years;Time to Disease WorseningTimepoint: Up to 4 years;Time to ProgressionTimepoint: Up to 4 years	—

Measure

Time frame

Change from Baseline in EORTC QLQ- Non- Muscle-Invasive Bladder Cancer (NMIBC) 24Timepoint: Baseline up to 4 years;Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30Timepoint: Baseline up to 4 years;Change from Baseline in EuroQol European Quality of Life – 5 Dimensions-5 Levels (EQ-5D-5L)Timepoint: Baseline up to 4 years;Change from Baseline in Patient’s Global Impression of Change (of cancer) (PGIC)Timepoint: Baseline, Cycle 2 Day 1 and end of treatment (up to 2 years) (each cycle is of 28 days);Change from Baseline in Patient’s Global Impression of Severity (of cancer) (PGIS)Timepoint: Baseline up to 4 years;Disease-Specific SurvivalTimepoint: Up to 4 years;Number of Participants with Adverse eventsTimepoint: Up to 4 years;Overall SurvivalTimepoint: Up to 4 years;Plasma Concentration of ErdafitinibTimepoint: Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28 days);Recurrence-Free SurvivalTimepoint: Months 6, 12, and 24;Recurrence-Free Survival 2 (RFS2)Timepoint: Up to 4 years;RFS by Central Histopathologic ReviewTimepoint: Up to 4 years;Time to Disease WorseningTimepoint: Up to 4 years;Time to ProgressionTimepoint: Up to 4 years

—

Countries

Argentina, Australia, Belgium, Brazil, China, Czech Republic, France, Germany, India, Italy, Japan, Poland, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactDr Sanish Davis

Johnson and Johnson Private Limited

sdavis20@its.jnj.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026